FDA Suspends Sunland Peanut Butter Plant

First use of agency's newly granted authority

For the first time in agency history, the U.S. Food and Drug Administration on Monday used its authority to suspend the registration of peanut butter processor Sunland Inc. of Portales, N.M., the plant connected to a Salmonella outbreak that has sickened at least 41 people across 20 states. Without a proper FDA registration, Sunland — the country’s largest organic peanut butter producer — would be prohibited from selling any products within America.

The FDA was granted the authority to suspend registrations when the U.S. Food Safety Modernization Act was signed into law on January 4, 2011.

The agency cited Sunland’s recent outbreak and its history of health violations as the reason for this suspension. The company has had trouble with Salmonella for several years, including multiple instances of environmental contamination from at least nine different Salmonella strains.

“A review of Sunland Inc.’s product testing records showed that 11 product lots of nut butter showed the presence of Salmonella between June 2009 and September 2012,” an emailed FDA statement read. “Between March 2010 and September 2012, at least a portion of 8 product lots of nut butter that Sunland Inc.’s own testing program identified as containing Salmonella was distributed by the company to consumers.”

During an inspection of the plant beginning in September 2012, FDA found Salmonella in 28 environmental samples, 13 nut butter product samples, and one sample of raw peanuts. Four of those nut butter product samples contained Salmonella Bredeney, the strain at the center of the current outbreak.

Sunland has denied shipping any contaminated product to consumers, saying anything that tested positive for pathogens was destroyed.

“At no time in its 24-year history has Sunland, Inc. released for distribution any products that it knew to be potentially contaminated with harmful microorganisms,” President and CEO Jimmie Shearer wrote in a statement on the company’s website.

Sunland voluntarily ceased operations in September after the announcement of the outbreak. On Monday morning, the Associated Press reported that Sunland would restart its operations Tuesday, with hopes of making peanut butter again before the end of the year.

That announcement, however, seems to have come just hours before the FDA issued its registration suspension. Speaking to Food Safety News, an FDA spokeswoman confirmed that, as of Monday, Sunland will not be allowed to sell any products until proving it has “implemented procedures to produce safe products.”

It is unclear whether Sunland will halt production until the suspension is lifted. Calls to the company were not returned Monday afternoon.

Sunland may request an informal hearing with FDA to address the suspension. If the hearing does not alleviate FDA’s concerns, the company will be asked to submit a “corrective action plan” to mitigate its problems scientifically.

This news comes within weeks of alerts being sent to consumers in numerous countries over concerns that Sunland products may have been imported to places such as Canada, Hong Kong and the European Union.

The outbreak also comes roughly four years after peanut products manufactured by the Peanut Corporation of America sickened at least 714 people across 46 states in an outbreak of Salmonella Typhimurium. According to Kenneth Kendrick, a former assistant manager at Peanut Corporation’s Texas plant, Sunland supplied organic Valencia peanuts to Peanut Corporation around the time of that outbreak.

None of the nine Salmonella strains detected in Sunland’s facilities were Typhimurium, and no evidence exists to suggest a connection between Sunland and Peanut Corporation’s outbreak. Regardless, Kendrick said that the FDA should have been more proactive in investigating Peanut Corporation’s suppliers after such a massive outbreak.

“There’s no excuse for the FDA not to have investigated Sunland back in 2009,” Kendrick told Food Safety News. “They were all over Peanut Corp’s shipping records — their suppliers should have been looked at. We might have stopped these kids [in the Sunland outbreak] from getting sick.”

Question for the FSMA experts out there… Is this statement true? “Without a proper FDA registration, Sunland — the country’s largest
organic peanut butter producer — would be prohibited from selling any
products within America.”

Or does an FDA registration only apply to interstate commerce? Can Sunland continue to manufacture and sell product as long as all ingredients are supplied from and all products are sold within the state?

http://www.foodsafetynews.com/ Food Safety News Information

Hi Beth,

Good question. The FDA registration suspension does in fact restrict all commerce, including that within the state.

http://www.foodsafetynews.com/ Food Safety News Information

From the FDA’s emailed statement to reporters:

“Registration with the FDA is required for any facility that manufactures, processes, packs, or holds food for consumption in the United States. If a facility’s registration is suspended, that facility is prohibited from introducing food into interstate or intrastate commerce.”

http://twitter.com/grapedoc Steve Savage

It is interesting. Between 2008 and 2011 USDA data shows a 54% drop in organic peanut acreage in the US and a 52% drop in production. Sunland may well have become the biggest player in the organic segment by cutting corners on things like basic safe practices. I would be fascinated to know how their products stack up in terms of aflatoxin levels.

http://twitter.com/FoodieBusiness sam klepfish

Question: did anyone notice the seemingly significant fact that the FDA is using CFR 16.26 to give the FDA the right to even deny the informal hearing if “no genuine and substantial issue of fact has been raised by the material submitted”
This may in fact be standard for “normal” FDA hearings, other then under the FMSA but in all the materials on the FDA website and in the actual text of the bill “The Secretary shall provide the registrant subject to an order under paragraph (1) with an opportunity for an informal hearing,” it does not seem to indicate that the informal hearing could in fact be denied.
This is significant in some ways- as basically there is no opportunity for a company to have their grievances heard if they are under a suspension; if in fact the commissioner or others deny the hearing based on “no new facts”. I wonder if the bill had that broad of scope in mind. ? thoughts ?